Running oncology studies globally

We plan & execute seamless clinical trials with novel study designs

90%

Project Managers

have oncology experience.

PSI’s key differentiator is our ability to plan and execute complex clinical trials on time, saving our customers millions of development dollars.

We have diverse experience in various classes of small molecules and biologics across a broad spectrum of cancers, including lung, breast, GI, GU, skin, leukemias, lymphomas, multiple myeloma, and MPNs. Our deep experience goes even further, including:

  • Immunotherapies (including checkpoint inhibitors, cancer vaccines, CAR-T cell therapies, bispecific antibodies and cytokines)
  • Radiopharmaceuticals (in diagnostic and therapeutic setting)
  • Cancer supportive care medications (in cytopenias, nausea/vomiting, mucositis, fungal infections)
  • Biosimilar medicines
  • Early phase studies including basket/umbrella designs


Patient populations

• PSI works with hundreds of sites in six continents in a variety of oncological indications.
• 90% of our Project Managers and 79% of our CRAs have oncology experience.
• PSI aced multiple FDA and EMA inspections resulting in drug approvals in breast, lung, prostate, colorectal, renal, pancreatic cancers, as well as various types of supportive care.

 

Novel Target Therapies

PSI has an impressive track-record of managing studies of checkpoint inhibitors and other IO agents/target biologics. Increasingly breakthrough therapies are being identified earlier, and some are being approved based on a single combined phase I/II trials. More and more common is to see new target therapies being studied for multiple tumor targets, and in combination with other drugs in multiple regimens.

PSI has cultivated alliances with laboratories known for their expertise in Next Generation Sequencing as well as technology companies that specialize in Artificial Intelligence platforms for analysis of medical and genetic data, which enables recruiting subsets of ultra-rate patients sharing the same actionable target. Add those alliances to our large network of valued, global sites, and you can see a CRO that is truly committed to on-time enrollment.

Biosimilars in Oncology

Thanks to PSI’s broad access to sites in the developing countries, PSI remains a key player in providing successful patient enrollment and full-service management of biosimilar oncology trials. Our sites all over Eastern Europe, India, South Africa and Latin American countries often play an important role in enabling speedy patient enrollment and high quality of data for trials that turn out to be particularly difficult to execute in more Western countries.

Valued Sites Network

PSI recognizes that site relationships play an integral role in clinical trial success. We proactively cultivate those relationships by reaching out internationally to identify and recruit an elite group of top performing sites and investigators who share our commitment to optimize access to eligible patients, decrease start-up times and administrative burden and enable multiple efficiencies which support PSI’s goal to consistently deliver high quality clinical trials on time and on budget.

Our Valued Site network includes a cadre of sites including leading academic centers, community cancer centers, private oncology practices and site networks willing to enter into pro-active business agreements and interested in pursuing a mutually beneficial multi-study relationship with PSI.

We work collaboratively with our Valued Sites to develop streamlined processes which decrease start-up timelines and promote efficiencies for our sponsors, sites, and PSI. Not only do these arrangements decrease workload, but Valued Sites also enjoy special privileges which afford investigators opportunities to participate in focus groups or provide early input on protocols or product development which serve their specific research interests. We understand the need to have products reach the market and patients quickly. Utilizing the PSI Valued Site network can help support that goal.

Case Study

Mindful clinical trials

What does risk-based monitoring have to do with it?

Whitepaper

PSI takes top spot in global CRO survey

2017 CentreWatch investigator survey ranks 12 CROs worldwide.

“PSI has been exceedingly professional and is respected by our site as a great collaborator.”

Anthony W. Tolcher, MD, FRCP, FACP

Your Oncology Study Moving Ahead

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Today, PSI is the largest CRO of its size (over 2,200 employees) that is still, after 25+ years, privately owned by its management. With zero outside investment or debt, PSI has been independent, consistent, and stable. Operating in more than 60+ countries with offices all around the world, we know that customer and staff loyalty are core to our growth.

But, our low staff turnover rates aren’t just a testament to our success: they’re a promise to the success of your oncology study. Time and time again, our dedicated teams deliver your projects on time. And that means that all over the world, you can guarantee that when you team up with PSI to run your study, you’ll see results.

The PSI Advantage

Ranked #1 Global CRO by Investigators Worldwide. CenterWatch 2015-2017

 

Therapeutic areas

Inflammatory Bowel Diseases (IBD)

Crohns’ Disease, Ulcerative Colitis and other IBDs.

Oncology

Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer and other Oncology indications.

Hematology

Multiple Myeloma, Lymphomas, Leukemias and other oncohematological indications.

Infectious Diseases

Antimicrobial and Antifungal infections and other ID.

Multiple Sclerosis

Multiple Sclerosis, Spasticity and other neurological indications.

Rare Diseases

Hemophilia A & B, Von Willebrand Disease, Thrombocytopenia, Polycythemia Vera, Paroxysmal Nocturnal Hemoglobinuria (PNH).